Efficacy and Safety of Involving Field Radiotherapy in the Oligo-lesions(Metastasis/Recurrent/Refractory) of Ovarian Cancer

September 25, 2021 updated by: Liu Zi, Health Science Center of Xi'an Jiaotong University
In this study, The researchers sought to explore the efficacy and safety of involving field radiotherapy in the oligo-metastatic/recurrent/refractory ovarian cancer patients among different groups which include drug therapy alone, radiotherapy alone, and drug therapy plus radiotherapy by inviting clinical multi-center participation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The recurrent or refractory ovarian cancer tends to recur repeatedly at increasingly short intervals, making treatment more and more difficult.Patients often have limited physical capacity to undergo repeated systematic treatment. Currently, NCCN（ national comprehensive cancer network ）guidelines recommend palliative radiotherapy in patients with local recurrence of ovarian cancer. With the progress of IMRT（ intensity modulated radiation therapy ）, SBRT ( stereotactic body radiation therapy ) and other radiotherapy technologies, better local tumor control rate can also be achieved, while minimizing the damage to surrounding normal tissues. In this study, the patients will be divided into groups according to their wishes: group A (drug therapy alone), group B (radiotherapy alone), and group C (radiotherapy plus drug therapy).The researchers sought to explore the the efficacy and safety of involving field radiotherapy in the oligo-metastatic/recurrent/refractory ovarian cancer patients in different groups after treatment by inviting multiple centers to participate in the study.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • The First Affiliated Hospital of Xi'an Jiao Tong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Age ≥18;
  2. Evidence of histological diagnosis of ovarian cancer (including fallopian tube cancer and primary peritoneal cancer)
  3. Pathology or imaging suggested recurrence, with measurable lesions, and the number of lesions ≤3;
  4. No serious hematopoietic dysfunction, abnormal heart, lung, liver, kidney and immune deficiency
  5. Cooperative Oncology Group-Status (ECOG Status) score 0-2;
  6. Expected survival ≥3 months;
  7. Feasible abdomen and pelvic cavity MRI/CT;
  8. Good compliance, signed informed consent voluntarily.

Exclusion Criteria:

  1. Previous radiotherapy at the target lesion site;
  2. History of active inflammatory bowel disease or severe stomach and duodenal ulcers;
  3. Human immunodeficiency virus (HIV) infected persons;
  4. active hepatitis b (HBVDNA quantitative test results exceed the lower limit), or HCV infection (HCVRNA quantitative test results exceed the lower limit);
  5. suffering from serious underlying diseases, including but not limited to active infections requiring systemic medication:
  6. patients with a history of other malignant tumors (except cured basal cell carcinoma of the skin);
  7. neurological or mental disorders that affect cognitive ability;
  8. Patients whose lesions have been evaluated by the investigator and cannot be treated with external irradiation or endovascular radiation therapy;
  9. those who cannot follow up regularly as prescribed by the doctor;
  10. Other reasons not suitable for participating in this study as judged by the researcher.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A (drug treatment group)
Group A (drug treatment group) : Chemotherapy drugs ,targeted drugs or Immune checkpoint inhibitors are taken throughout the body or a combination of these drugs according to clinical needs is performed when necessary.
Drug: chemotherapy, targeted therapeutics, immunotherapy
Chemotherapy drugs ,targeted drugs or Immune checkpoint inhibitors are taken throughout the body or a combination of these drugs according to clinical needs is performed when necessary.
Experimental: Group B (radiotherapy group)
IFRT, IMRT or SBRT is applied. Irradiation techniques and doses can be selected based on the previous experience of each center, but all patients enrolled within the center need to be consistent.
Radiation: IFRT, IMRT or SBRT
IFRT（involving field radiotherapy） IMRT （ intensity modulated radiation therapy） SBRT （stereotactic body radiation therapy）
Experimental: Group C (radiotherapy + drug group)
Drug therapy is the same as group A; IFRT is the same as group B.
Drug: chemotherapy, targeted therapeutics, immunotherapy
Chemotherapy drugs ,targeted drugs or Immune checkpoint inhibitors are taken throughout the body or a combination of these drugs according to clinical needs is performed when necessary.
Radiation: IFRT, IMRT or SBRT
IFRT（involving field radiotherapy） IMRT （ intensity modulated radiation therapy） SBRT （stereotactic body radiation therapy）

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local Control ( LC )
Time Frame: 6 months
LC will be measured from the start date of treatment until the date of progressive of the target lesion
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival ( PFS )
Time Frame: 24 months
PFS is defined as the time from first day of treatment until the first date of either objective disease progression or death due to any cause
24 months
Overall Survival ( OS ）
Time Frame: 24 months
OS is defined as the time from first day of treatment until the date of death due to any cause or the deadline for the study
24 months
Rate of Radiation-related Adverse Reactions
Time Frame: 24 months
Rate of acute and late adverse reactions associated with radiotherapy
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Health Science Center of Xi'an Jiaotong University

Investigators

  • Principal Investigator: Zi Liu, Ph.d, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 10, 2021

Primary Completion (Anticipated)

February 28, 2023

Study Completion (Anticipated)

September 1, 2024

Study Registration Dates

First Submitted

September 13, 2021

First Submitted That Met QC Criteria

September 25, 2021

First Posted (Actual)

September 28, 2021

Study Record Updates

Last Update Posted (Actual)

September 28, 2021

Last Update Submitted That Met QC Criteria

September 25, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCR-04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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